Pinsker, Jordan E.
https://orcid.org/0009-0004-7621-5267
Mayo Clinic
Tandem Diabetes Care (United States)
Citations 2
A Multicenter Study of an Investigational Extended Wear Insulin Infusion Set in Adults with Type 1 Diabetes
Lal, Rayhan A. , Lum, John W. , Reed, Zachariah W., Kruger, Davida , Reed, John Chip, Weinstock, Ruth S. , Carlson, Anders L. , Kudva, Yogish C. , Liljenquist, David R., Levister, Camilla, Broyles, Frances E. , Pinsker, Jordan E. , Romey, Matt, Lehman, Avi, Muchmore, Douglas B. , Kollman, Craig, Group, for the CB1 Study, Hirsch, Irl B , Pinsker, Jordan E , Beck, Roy W , Lal, Rayhan A , Lal, Rayhan A. , Reed, John H. Chip, Aleppo, Grazia , Chen, Jean, Ahn, David , Hirsch, Irl B. , Putman, Melissa S. , Pinsker, Jordan E. , Beck, Roy W. , Group, for the CB1 Study
Diabetes Technology & Therapeutics | September 30, 2025 | Volume: 28 | Issue: 1 | Pages: 1-9
Objective: To evaluate the function and safety of the SteadiSet™ infusion set over a continuous 7-day wear period in adults with type 1 diabetes. Research Design and Methods: Participants used a SteadiSet infusion set with a t:slim X2™ insulin pump with Control-IQ™ technology, and either insulin aspart or insulin lispro, for a target of 7 days for 12 consecutive wear periods. Each set removed before 7 days was adjudicated by an independent committee to assess the cause of early removal and to determine whether criteria for primary or key secondary endpoints were met. Results: There were 260 participants who inserted 3028 infusion sets. For the primary endpoint, the Kaplan–Meier 7-day survival estimate was 95% (95% CI 94% to 96%). For the key secondary endpoint, which expanded the reasons for a failed infusion set, the Kaplan–Meier 7-day survival estimate was 84% (95% CI 82% to 86%). For both endpoints, the P value was <0.001 compared with a prespecified survival rate of 75%. Time-in-range 70–180 mg/dL (TIR) increased through day 3 of set wear and then decreased through day 7, with the average TIR being 70.6% over the entire wear period across all infusion sets, including those that failed. An increase in total daily insulin was observed from day 4 through day 7. Conclusions: The 7-day survival of the SteadiSet infusion set was very high for the primary endpoint and at an acceptable level with respect to early removal for any reason related to the device.
Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial
O’Malley, Grenye , Messer, Laurel H. , Pinsker, Jordan E. , Forlenza, Gregory P. , Isganaitis, Elvira , Kudva, Yogish C. , Ekhlaspour, Laya , Raghinaru, Dan, Lum, John W. , Brown, Sue A. , Kovatchev, Boris, Anderson, Stacey M. , Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Laffel, Lori M. , E.I., Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, J.E.P., Church, Mei Mei , André, Camille , Piper, Molly, C.J.L., Lam, David W. , G.O., Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Wadwa, R. Paul, Alonso, G. Todd, Slover, Robert H., Jost, Emily , L.H.M., Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, L.E., Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Paulson, John A., Beck, Jan-Philipp, Passman, Samantha, Campos, Tiffany, Kollman, D.R. Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas L., Green, Neal, Kovatchev, Boris, Arreza-Rubin, Guillermo, J.E.P., C.J.L., Y.C.K., Wadwa, R. Paul, Reznik, Yves , Arreza-Rubin, Guillermo, Buckingham, Bruce A. , Forlenza, Gregory P , Messer, Laurel H , Buckingham, Bruce , Levy, Carol J. , Pinsker, Jordan E. , Kovatchev, Boris , Kovatchev, Boris, Oliveri, Mary Clancy , E.I., J.E.P., C.J.L., G.O., Wadwa, R Paul , Kumari, Kanchan , Wadwa, R. Paul, L.H.M., L.E., Town, Marissa, Paulson, John A., Patibandla, Nandan, Arreza-Rubin, Guillermo, Kovatchev, Boris, Arreza-Rubin, Guillermo, J.E.P., C.J.L., Y.C.K., Wadwa, R. Paul, Renard, Eric , Cobelli, Claudio , Arreza-Rubin, Guillermo
Diabetes Technology & Therapeutics | November 6, 2020 | Volume: 23 | Issue: 4 | Pages: 245-252
Background: Data are limited on the need for and benefits of pump setting optimization with automated insulin delivery. We examined clinical management of a closed-loop control (CLC) system and its relationship to glycemic outcomes. Materials and Methods: We analyzed personal parameter adjustments in 168 participants in a 6-month multicenter trial of CLC with Control-IQ versus sensor-augmented pump (SAP) therapy. Preset parameters (BR = basal rates, CF = correction factors, CR = carbohydrate ratios) were optimized at randomization, 2 and 13 weeks, for safety issues, participant concerns, or initiation by participants' usual diabetes care team. Time in range (TIR 70–180 mg/dL) was compared in the week before and after parameter changes. Results: In 607 encounters for parameter changes, there were fewer adjustments for CLC than SAP (3.4 vs. 4.1/participant). Adjustments involved BR (CLC 69%, SAP 80%), CR (CLC 68%, SAP 50%), CF (CLC 44%, SAP 41%), and overnight parameters (CLC 62%, SAP 75%). TIR before and after adjustments was 71.2% and 71.3% for CLC and 61.0% and 62.9% for SAP. The highest baseline HbA 1c CLC subgroup had the largest TIR improvement (51.2% vs. 57.7%). When a CR was made more aggressive in the CLC group, postprandial time >180 mg/dL was 43.1% before the change and 36.0% after the change. The median postprandial time <70 mg/dL before making CR less aggressive was 1.8%, and after the change was 0.7%. Conclusions: No difference in TIR was detected with parameter changes overall, but they may have an effect in higher HbA 1c subgroups or following user-directed boluses, suggesting that changes may matter more in suboptimal control or during discrete periods of the day. Clinical Trials Registration number: NCT03563313.